Trial Outcomes & Findings for A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021) (NCT NCT02039674)
NCT ID: NCT02039674
Last Updated: 2022-11-08
Results Overview
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
267 participants
Primary outcome timeframe
Up to approximately 2 years
Results posted on
2022-11-08
Participant Flow
This results disclosure is based on efficacy data cutoff dates of 08-Aug-2016 for Cohorts C and G (primary endpoint); 07-Nov-2016 for Cohorts A, B, D, E, F and H; and 19-Aug-2019 for Cohort G (secondary endpoints).
Participant milestones
| Measure |
Part1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve \[AUC\] 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part1 Cohort A10 (Pembro10mg/kg+Pa+C)
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (C 5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort H (Pembro 2mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
13
|
12
|
12
|
3
|
3
|
12
|
12
|
7
|
60
|
63
|
33
|
|
Overall Study
Treated
|
13
|
12
|
11
|
13
|
12
|
12
|
3
|
3
|
12
|
12
|
7
|
59
|
62
|
33
|
|
Overall Study
Received Second Course of Pembrolizumab
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Switched Over to Pembrolizumab
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
12
|
13
|
12
|
12
|
3
|
3
|
12
|
12
|
7
|
60
|
63
|
33
|
Reasons for withdrawal
| Measure |
Part1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve \[AUC\] 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part1 Cohort A10 (Pembro10mg/kg+Pa+C)
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (C 5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort H (Pembro 2mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
3
|
1
|
|
Overall Study
Death
|
2
|
0
|
2
|
3
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
3
|
2
|
8
|
|
Overall Study
Excluded Medication
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
3
|
5
|
6
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Progressive Disease
|
8
|
8
|
6
|
7
|
9
|
10
|
1
|
3
|
6
|
4
|
0
|
34
|
34
|
18
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
4
|
6
|
2
|
|
Overall Study
Clinical Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
3
|
0
|
8
|
5
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
Baseline characteristics by cohort
| Measure |
Part1CohortA2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
n=13 Participants
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve \[AUC\] 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part1CohortA10 (Pembro10mg/kg+Pa+C)
n=12 Participants
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
n=12 Participants
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
n=13 Participants
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
n=12 Participants
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
n=12 Participants
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
n=3 Participants
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
n=3 Participants
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
n=12 Participants
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
n=12 Participants
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
n=7 Participants
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=60 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
n=63 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort H (Pembro 2 mg/kg+I)
n=33 Participants
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
61.4 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
61.2 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
60.3 Years
STANDARD_DEVIATION 11.0 • n=21 Participants
|
63.3 Years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
69.3 Years
STANDARD_DEVIATION 6.0 • n=8 Participants
|
59.3 Years
STANDARD_DEVIATION 5.5 • n=24 Participants
|
55.3 Years
STANDARD_DEVIATION 14.0 • n=42 Participants
|
60.2 Years
STANDARD_DEVIATION 8.0 • n=42 Participants
|
62.7 Years
STANDARD_DEVIATION 12.0 • n=42 Participants
|
61.8 Years
STANDARD_DEVIATION 9.2 • n=42 Participants
|
63.2 Years
STANDARD_DEVIATION 9.6 • n=36 Participants
|
62.2 Years
STANDARD_DEVIATION 9.7 • n=36 Participants
|
61.8 Years
STANDARD_DEVIATION 9.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
37 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
147 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
26 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
120 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The analysis population consisted of all randomized Cohort G participants (database cutoff date: 08 August 2016).
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Outcome measures
| Measure |
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=60 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
n=63 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
|
55.0 Percentage of Participants
Interval 41.6 to 67.9
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28.6 Percentage of Participants
Interval 17.9 to 41.3
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PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The analysis population consisted of all treated Cohort D4 and Cohort H participants (database cutoff date: 07 November 2016). One Cohort H participant was excluded from the efficacy analysis population due to a protocol violation. This participant did not have non-small cell lung cancer.
For participants who demonstrated a confirmed response (Complete Response \[CR\]: Disappearance of all target lesions or Partial Response \[PR\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Outcome measures
| Measure |
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=44 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
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29.5 Percentage of Participants
Interval 16.8 to 45.2
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PRIMARY outcome
Timeframe: Cycle 1 (Up to 21 days)Population: The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting \>3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for \>1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia \<25,000/mm\^3; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing \>10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
Outcome measures
| Measure |
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=13 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
n=12 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
n=11 Participants
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
n=13 Participants
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
n=12 Participants
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
n=12 Participants
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
n=3 Participants
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D2 (Pembro 10 mg/kg+I)
n=3 Participants
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D4 (Pembro 2 mg/kg+I)
n=12 Participants
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
n=12 Participants
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
n=7 Participants
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=59 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
n=62 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort H (Pembro 2 mg/kg+I)
n=33 Participants
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The analysis population consisted of all randomized Cohort G participants (database cutoff date: 19 August 2019).
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.
Outcome measures
| Measure |
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=60 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
n=63 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
|
24.5 Months
Interval 9.7 to 36.3
|
9.9 Months
Interval 6.2 to 15.2
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—
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—
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SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The analysis population consisted of all randomized Cohort G participants (database cutoff date: 19 August 2019).
OS was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=60 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
n=63 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 Cohorts G+ and G-: Overall Survival (OS)
|
34.5 Months
Interval 24.0 to
NA=Upper limit of OS not reached.
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21.1 Months
Interval 14.9 to 35.6
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SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The analysis population consisted of all randomized Cohort G participants who experienced a confirmed response (CR or PR); (database cutoff date: 19 August 2019).
For participants who demonstrated a confirmed response (Complete Response \[CR\]: Disappearance of all target lesions or Partial Response \[PR\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Outcome measures
| Measure |
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=35 Participants
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
n=21 Participants
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort H (Pembro 2 mg/kg+I)
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
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Part 2 Cohorts G+ and G-: Duration of Response (DOR)
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NA Months
NA=DOR median not reached at time of data cut-off due to insufficient number of responding participants with relapse.
NA=DOR lower and upper limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
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NA Months
NA=DOR median not reached at time of data cut-off due to insufficient number of responding participants with relapse.
NA=DOR lower and upper limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
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Adverse Events
Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)
Serious events: 5 serious events
Other events: 12 other events
Deaths: 10 deaths
Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Serious events: 7 serious events
Other events: 13 other events
Deaths: 10 deaths
Cohort A Second Course (Pembro 2 mg/kg Monotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
Serious events: 8 serious events
Other events: 12 other events
Deaths: 11 deaths
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Serious events: 8 serious events
Other events: 11 other events
Deaths: 9 deaths
Cohort B Second Course (Pembro 2 mg/kg Monotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
Serious events: 7 serious events
Other events: 12 other events
Deaths: 11 deaths
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
Serious events: 5 serious events
Other events: 12 other events
Deaths: 11 deaths
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
Serious events: 8 serious events
Other events: 12 other events
Deaths: 5 deaths
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
Cohort E Second Course (Pembro 2 mg/kg Monotherapy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
Serious events: 30 serious events
Other events: 58 other events
Deaths: 42 deaths
Part 2 Cohort G- (Placebo+Pe+C)
Serious events: 21 serious events
Other events: 60 other events
Deaths: 47 deaths
Cohort G+ Second Course (Pembro 200 mg Monotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort G Crossover (Pembro 200 mg Monotherapy)
Serious events: 7 serious events
Other events: 24 other events
Deaths: 24 deaths
Part 2 Cohort H (Pembro 2mg/kg+I)
Serious events: 12 serious events
Other events: 30 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)
n=12 participants at risk
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
n=13 participants at risk
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Cohort A Second Course (Pembro 2 mg/kg Monotherapy)
n=2 participants at risk
Cohort A Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
n=13 participants at risk
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
n=11 participants at risk
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Cohort B Second Course (Pembro 2 mg/kg Monotherapy)
n=1 participants at risk
Cohort B Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
n=12 participants at risk
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
n=12 participants at risk
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
n=3 participants at risk
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D2 (Pembro 10 mg/kg+I)
n=3 participants at risk
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort D4 (Pembro 2 mg/kg+I)
n=12 participants at risk
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
n=12 participants at risk
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
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Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
n=7 participants at risk
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
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Cohort E Second Course (Pembro 2 mg/kg Monotherapy)
n=1 participants at risk
Cohort E Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=59 participants at risk
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort G- (Placebo+Pe+C)
n=62 participants at risk
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
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Cohort G+ Second Course (Pembro 200 mg Monotherapy)
n=2 participants at risk
Cohort G+ Second Course participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.
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Cohort G Crossover (Pembro 200 mg Monotherapy)
n=28 participants at risk
Cohort G Crossover participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.
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Part 2 Cohort H (Pembro 2mg/kg+I)
n=33 participants at risk
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
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Cardiac disorders
Cardiogenic shock
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0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diverticular perforation
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Death
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood pressure increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
71.4%
5/7 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
71.4%
5/7 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Liver function test increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Transaminases increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Troponin increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neuralgic amyotrophy
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
Other adverse events
| Measure |
Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)
n=12 participants at risk
Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])
n=13 participants at risk
Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Cohort A Second Course (Pembro 2 mg/kg Monotherapy)
n=2 participants at risk
Cohort A Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)
n=13 participants at risk
Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
n=11 participants at risk
Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Cohort B Second Course (Pembro 2 mg/kg Monotherapy)
n=1 participants at risk
Cohort B Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)
n=12 participants at risk
Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)
n=12 participants at risk
Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])
n=3 participants at risk
Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D2 (Pembro 10 mg/kg+I)
n=3 participants at risk
Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort D4 (Pembro 2 mg/kg+I)
n=12 participants at risk
Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)
n=12 participants at risk
Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)
n=7 participants at risk
Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
Cohort E Second Course (Pembro 2 mg/kg Monotherapy)
n=1 participants at risk
Cohort E Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G+ (Pembro 200 mg+Pe+C)
n=59 participants at risk
Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort G- (Placebo+Pe+C)
n=62 participants at risk
Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
|
Cohort G+ Second Course (Pembro 200 mg Monotherapy)
n=2 participants at risk
Cohort G+ Second Course participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.
|
Cohort G Crossover (Pembro 200 mg Monotherapy)
n=28 participants at risk
Cohort G Crossover participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.
|
Part 2 Cohort H (Pembro 2mg/kg+I)
n=33 participants at risk
Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
45.5%
5/11 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Emotional poverty
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.4%
15/59 • Number of events 22 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.5%
9/62 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.5%
9/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Deafness
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
6/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
35.6%
21/59 • Number of events 33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
58.1%
36/62 • Number of events 41 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.3%
7/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
36.4%
4/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.3%
9/59 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
17.9%
5/28 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
24.2%
8/33 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Asthenopia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Blepharitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Cataract
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.9%
10/59 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Eye discharge
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Eye disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Eye irritation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Eyelid rash
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Glaucoma
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Iritis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.9%
10/59 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.5%
9/62 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Uveitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Vision blurred
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Visual impairment
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
100.0%
1/1 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
13.6%
8/59 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Cheilitis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
58.3%
7/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
61.5%
8/13 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
81.8%
9/11 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
58.3%
7/12 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
8/12 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
54.2%
32/59 • Number of events 41 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
40.3%
25/62 • Number of events 30 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
9/33 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
8/12 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
57.1%
4/7 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
44.1%
26/59 • Number of events 39 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.6%
19/62 • Number of events 32 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
21.4%
6/28 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
6/33 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
13.6%
8/59 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Haematemesis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Haematochezia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
53.8%
7/13 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
46.2%
6/13 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
63.6%
7/11 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
58.3%
7/12 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
72.9%
43/59 • Number of events 88 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
59.7%
37/62 • Number of events 51 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
21.4%
6/28 • Number of events 12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
21.2%
7/33 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oral papule
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 16 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.7%
6/62 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Tongue erythema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
36.4%
4/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
47.5%
28/59 • Number of events 59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
32.3%
20/62 • Number of events 25 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
17.9%
5/28 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
24.2%
8/33 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Catheter site pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chills
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Face oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Facial pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
66.7%
8/12 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
61.5%
8/13 • Number of events 12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
72.7%
8/11 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
91.7%
11/12 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
6/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
100.0%
3/3 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
58.3%
7/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
69.5%
41/59 • Number of events 73 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
58.1%
36/62 • Number of events 42 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
7/28 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
48.5%
16/33 • Number of events 21 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Gait disturbance
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Generalised oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
100.0%
1/1 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Localised oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.1%
16/59 • Number of events 22 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
24.2%
15/62 • Number of events 19 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pain
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
17.9%
5/28 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Swelling
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Temperature intolerance
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Xerosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Drug hypersensitivity
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Candida infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Eye infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Furuncle
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Otitis media
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Paronychia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pustule
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.7%
6/62 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
13.6%
8/59 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.7%
14/59 • Number of events 23 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
20.3%
12/59 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
4/28 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.9%
10/59 • Number of events 15 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.6%
11/59 • Number of events 17 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
19.4%
12/62 • Number of events 17 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
20.3%
12/59 • Number of events 19 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
24.2%
15/62 • Number of events 20 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.3%
7/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.4%
15/59 • Number of events 19 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.3%
7/62 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood glucose increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood potassium increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood urea increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.6%
11/59 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.9%
8/62 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.9%
8/62 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Tri-iodothyronine decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
13.6%
8/59 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.5%
9/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.2%
5/33 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight increased
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.9%
8/62 • Number of events 13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.7%
5/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
53.8%
7/13 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
53.8%
7/13 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
37.3%
22/59 • Number of events 29 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.4%
17/62 • Number of events 21 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
32.1%
9/28 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
6/33 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
20.3%
12/59 • Number of events 21 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.7%
6/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
20.3%
12/59 • Number of events 17 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.9%
8/62 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
46.2%
6/13 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
63.6%
7/11 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.9%
20/59 • Number of events 32 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
29.0%
18/62 • Number of events 25 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
4/28 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
24.2%
8/33 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
20.3%
12/59 • Number of events 18 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.9%
8/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
3/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
36.4%
4/11 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.3%
9/59 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.1%
4/33 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular surface squamous neoplasia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
6/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
100.0%
1/1 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.4%
15/59 • Number of events 19 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
19.4%
12/62 • Number of events 17 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
3/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.5%
9/62 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Head titubation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
36.4%
4/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.9%
20/59 • Number of events 30 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.6%
14/62 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
4/28 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
6/33 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
13.6%
8/59 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.1%
4/33 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Bladder prolapse
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urethral atrophy
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
53.8%
7/13 • Number of events 11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
53.8%
7/13 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
6/12 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.1%
16/59 • Number of events 21 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.4%
17/62 • Number of events 20 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
21.4%
6/28 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
6/33 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.7%
6/62 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.1%
4/33 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
40.7%
24/59 • Number of events 29 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.6%
14/62 • Number of events 16 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
4/28 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
24.2%
8/33 • Number of events 10 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
36.4%
4/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.5%
4/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 9 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.9%
7/59 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.7%
6/62 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
2/11 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.8%
4/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.3%
7/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
53.8%
7/13 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
61.5%
8/13 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
72.7%
8/11 • Number of events 8 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
20.3%
12/59 • Number of events 13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.1%
5/62 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
3/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Papule
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
23.1%
3/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
41.7%
5/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
42.9%
3/7 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.4%
15/59 • Number of events 21 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.3%
7/62 • Number of events 7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
12.1%
4/33 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
30.8%
4/13 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
38.5%
5/13 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
27.3%
3/11 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
6/12 • Number of events 15 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.9%
20/59 • Number of events 32 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.1%
10/62 • Number of events 14 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
4/28 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
4/12 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 4 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
10.2%
6/59 • Number of events 6 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.4%
2/59 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
5/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
3/12 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
13.6%
8/59 • Number of events 15 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
4.8%
3/62 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.6%
1/28 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
5.1%
3/59 • Number of events 5 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.2%
2/62 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.1%
2/28 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Pelvic venous thrombosis
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
2/13 • Number of events 3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Poor venous access
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
7.7%
1/13 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
1/11 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
3.0%
1/33 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
6.1%
2/33 • Number of events 2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/59 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/62 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/13 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/11 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
8.3%
1/12 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/12 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
1.7%
1/59 • Number of events 1 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/62 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/2 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/28 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/33 • Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment 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 study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER